Actively Recruiting
A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Led by Beijing Tongren Hospital · Updated on 2024-04-19
43
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with relapsed, refractory, or advanced Natural Killer/T-Cell Lymphoma (NKTCL) to explore a new combination treatment involving Linperlisib, Camrelizumab, and Pegaspargase. This prospective, single-arm clinical trial includes an initial safety phase (phase Ib) to determine the recommended dose and evaluate side effects, followed by phase II to assess the safety and effectiveness of this combined treatment in these patients. The treatment involves oral Linperlisib taken daily (80 mg in phase Ib; recommended phase II dose thereafter), intravenous Camrelizumab given every three weeks, and intramuscular Pegaspargase also given every three weeks. Each treatment cycle lasts 21 days. Dexamethasone is given on days 1 to 4 but not on the same day as Camrelizumab. The study includes close safety monitoring, especially for allergic reactions and infusion responses. Participants will be followed through at least six treatment cycles, with evaluations of tumor response at multiple points, including after the 2nd, 4th, and 6th cycles. Researchers will assess outcomes such as the best objective response rate, progression-free survival, overall survival, and disease control rate, with follow-up lasting up to two years. Safety monitoring will also include lab tests, imaging, and observation for adverse events throughout the study.
CONDITIONS
Brief Title
Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria
- Relapsed or refractory after initial remission, or Ann-Arbor stage III-IV de novo patients
- At least one objectively evaluable lesion by PET/CT or CT/MRI
- Expected survival of more than 3 months
- ECOG performance status score of 0 to 2
- Laboratory tests within 1 week before enrollment meeting blood and organ function thresholds: WBC ≥ 3×10⁹/L, PLT ≥ 75×10⁹/L, ANC ≥ 1.5×10⁹/L, serum creatinine ≤ 1.5 mg/dL, GFR ≥ 50 ml/min, ALT & AST ≤ 3 times upper limit, TBIL ≤ 2 times upper limit, serum fibrinogen ≥ 1.0 g/L
- Signed informed consent form
You will not qualify if you...
- Central nervous system involvement or other neoplasms
- Prior treatment with PI3K inhibitors
- Poor performance status, ECOG ≥ 3
- Lactation or pregnancy
- Men or women with potential for childbirth not using effective contraception
- Allergy to any study drugs
- Active infection
- History of immunodeficiency including HIV or organ transplantation
- History or suspicion of interstitial or non-infectious pneumonia
- History of neurological or psychiatric disorders including epilepsy or dementia
- Any other diseases judged by the researcher to seriously endanger patient safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration not specified
Participants receive an initial safety run-in phase with safety monitoring before the main enrollment to evaluate dose and toxicity.
Visits as needed for safety monitoring
Duration - Up to 18 weeks (6 cycles of 3 weeks each)
Participants receive Linperlisib orally daily, Camrelizumab intravenous infusion on day 1 of each 3-week cycle, Pegaspargase intramuscular injection on day 1 of each 3-week cycle, and Dexamethasone orally on days 1-4 of each cycle. Treatment cycles repeat every 3 weeks up to 6 cycles.
Visits on day 1 of each 3-week cycle with infusions and injections, plus additional visits for oral medication and monitoring
Duration - Up to 2 years
Participants are monitored for progression-free survival, overall survival, and disease control for up to 2 years after treatment.
Visits as scheduled for long-term safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Liang Wang
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Liang Wang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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